[Posted 10/20/2016]
AUDIENCE: Risk Manager, Oncology, Radiology
ISSUE: The FDA is concerned about the risks to patients from the use of devices manufactured and sold by Multidata Systems International Corporation ("Multidata").
The FDA knows of at least two Multidata medical devices that the company manufactured and distributed in the United States for which FDA never received nor reviewed 510(k) premarket notifications. These devices include: (1) accessories to radiation therapy devices including the Real Time Dosimetry (RTD) Waterphantom System and (2) the Dual Channel Electrometer. In addition, Multidata has not registered or listed their devices with the FDA, as required by federal law.
The FDA is concerned that health care providers may be unaware of the risks associated with these devices. At this time, it is not known how many devices manufactured by Multidata are currently in use in hospitals and clinics throughout the United States. The FDA is not aware of adverse event reports associated with the use of Multidata's devices since Multidata has been under the Decree.
BACKGROUND: Since 2003, Multidata has been under a Consent Decree of Permanent Injunction (the "Decree") entered by the U.S. District Court for the Eastern District of Missouri (civil action no. 4:03cv575). The Decree prohibits Multidata from designing, manufacturing, processing, and distributing medical devices, among other restrictions. The FDA has learned, however, that Multidata manufactured and distributed medical devices in violation of the Decree, including repairing and exchanging Waterphantom devices for newer design models.
RECOMMENDATIONS:
- Discontinue the use of any devices manufactured by Multidata and dispose of them appropriately.
- Use accessories to radiation therapy devices and radiation treatment planning software that have been cleared by the FDA. Registered manufacturers of these types of devices are listed under the IYE product code in the FDA’s Registration and Listing Database.
- Follow quality assurance procedures to verify treatment plans by independent means, which may include manual calculations or measurements of radiation doses.
- Report any adverse events related to Multidata devices that come to your attention. Voluntary reports can be submitted through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Device manufacturers and user facilities must comply with the applicable Medical Device Reporting (“MDR”) regulations. Health care personnel employed by facilities that are subject to FDA's user facility reporting requirements should follow the reporting procedures established by their facilities. Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices.
[10/20/2016 - Letter to Health Care Providers - FDA]
